A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax

This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge.

Study Overview

• Status: Recruiting
• Conditions: Anthrax

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Qin Ning, professor; Phone Number: 027-83665919; Email: qning@vip.sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Qin Ning, PHD,MD; Phone Number: +8602783662391; Email: qning@vip.sina.com
      • Principal Investigator: Qin Ning, PHD,MD
      • Sub-Investigator: Tao Chen, PHD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with severe anthrax

Description

Inclusion Criteria:

1. The typical bacilli with capsules were found in smear examination and culture of various secretions, excretions, blood and cerebrospinal fluid.
2. Multiple organ dysfunction (MODS) in brain, heart, liver, kidney, coagulation or more than one organ failure.

Exclusion Criteria:

There are other conditions that affect short-term survival.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
survival group; Patients who survived in 28 days/90 days
death group; Patients who survived in 28 days/90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rates of severe anthrax	mortality rates of severe anthrax	28 days and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of complications	To evaluate the incidence of respiratory, circulatory, neurological, digestive, coagulation and other complications of severe anthrax	in hospital
Peripheral blood biomarkers associated with 28-day and 90-day mortality	Peripheral blood biomarkers associated with 28-day and 90-day mortality	28 days and 90 days
the improvement in 28-day and 90-day mortality with treatment for severe anthrax	the improvement in 28-day and 90-day mortality with treatment for severe anthrax	28 days and 90 days

Collaborators and Investigators

• Sponsor: Qin Ning

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Bacillaceae Infections; Anthrax
• Other Study ID Numbers: TJIRB20231276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No